Reporting directly to the Chief Executive Officer (“CEO”), the Director of Regulatory Affairs (“DOR”) will assume primary responsibility for all Regulatory Affairs tasks within the Company. The DOR will be an integral part of the management team and may have up to twenty individuals within his/her supervision. The individual in this role must work closely and collaboratively with many individuals in the Company.  

Core Competencies and Characteristics of the Ideal Candidate: 

• ·         Previous experience interacting with senior regulatory affairs management at pharmaceutical and medical device companies, along with representatives of FDA and OHRP.
• ·         Knowledge of FDA regulations, HHS regulations, and ICH Guidelines, relevant state and local laws, and institutional policies, where applicable.
• ·         Knowledge of Human Subject Protection regulations and guidances & institutional conflict of interest polices and guidances with the ability to effectively educate/communicate to others on regulations, guidances and procedures
• ·         Previous experience participating in FDA audits.
• ·         Demonstrated leadership success  
• ·         Top-tier oral and written communication skills / Good database skills / customer service
• ·         Minimum of 5 years experience in regulatory affairs in clinical research
• ·         Highly organized with a strong attention to detail / Proven ability to meet deadlines
• ·         Team player with the ability to coach/mentor and work effectively with staff and with management

• ·         BS in life sciences required. MS/PhD highly preferable
• ·         Knowledge of AAHRPP and Canadian regulatory requirements is an asset
• ·         Previous experience on an IRB is an asset
• ·         Prior membership in research related professional organizations is an asset
  
  

  This tremendous opportunity will not be open for very long. For immediate consideration, please submit your resume in confidence to Celeste@TRAKcincy.com.